A laboratory information management system (LIMS) facilitates sample management and test execution against the specification criteria in a compliant, scientific platform to support GMP Quality and Manufacturing. Veeva LIMS connects to Veeva Quality and manages the quality control testing of manufactured batches for market release.
Veeva LIMS enables seamless information sharing between lab users, delivering real-time data for more informed decision-making. Automated digital workflows improve test efficiency, reliability, and accuracy. Veeva LIMS leverages functionality from connected applications, including quality document management and QMS objects.
Veeva LIMS Objects
There are two broad categories of components in the Veeva LIMS data model: Design Data components and Run Time components. Design Data includes the Test Definitions, Sample Plans, Lab Study Designs, and Spec Data, including the mapping of the components to particular Materials, Country, and Organization combinations, which allows LIMS to automatically select them upon batch creation. Veeva LIMS creates Runtime Data from Spec Data components and facilitates high volume, controlled data capture throughout the QC process, from sample collection to batch release.
Design Data
These objects and their supporting objects form the design from which Vault generates the runtime data records.
Runtime Data
When a user creates a runtime object, such as a Batch or Lab Sample, LIMS automatically selects the relevant Test Definition, Sample Plan, and Spec Data records for the selected Material, Country, and Organization combination and uses this to generate the runtime data records.
LIMS Terminology
When used in LIMS help articles, the following terms refer to specific Vault objects in the LIMS data model:
| Term | Vault Object | Definition |
|---|---|---|
| Test Definition | Lab Test Definition (lims_test_definition__v) |
The documented and validated process for performing a laboratory test. Aspirin Assay for example. Also known as a lab method. |
| Test Definition Step | Lab Test Definition Step (lims_test_definition_step__v) |
Each ordered individual step within a Test Definition. Also known as a method step. |
| Test Definition Input | Lab Test Definition Input (lims_test_definition_input__v) |
The consumables or instruments that are used in a test and should be captured in test execution. |
| Test Definition Result | Lab Test Definition Result (lims_test_definition_result__v) |
The attributes that define how a Lab Result will be displayed, how data will be entered, what values it will accept, and how those values will be formatted during test execution. |
| Test Definition Result Variable | Lab Test Definition Result Variable (lims_test_definition_result_variable__v) |
A child object of a calculated Lab Test Definition Result that defines a variable used in the calculation. This variable can be pulled from another result within the same Test Definition, a different Test Definition, an established constant, or an aggregate of multiple results. |
| Test Definition Variation | Lab Test Definition Variation (lims_test_definition_variation__v) |
A variation of a Test Definition that can be used to account for differences in tests such as analysis approach, product makeup, or units. Allows for defining results/inputs from the test definition to be used when a test is created from the variation. |
| Test Definition Variation Result | Lab Test Definition Variation Result (lims_test_definition_variation_result__v) |
Details the results captured during the analysis process for a specific variation of a Test Definition. |
| Test Definition Variation Input | Lab Test Definition Variation Input (lims_test_definition_variation_input__v) |
Details the reagents, standards, and equipment used during the analysis process specific to a variation of a Test Definition. |
| Sample Plan | Lab Sample Plan (lims_sample_plan__v) |
A collection of Sample Definitions that outline the sample collection process for a given batch of Lab Samples. |
| Sample Definition | Lab Sample Definition (lims_sample_definition__v) |
LIMS object that defines when a lab sample should be taken, and which lab methods should be executed against the sample according to a protocol. This concept does not exist outside of a written protocol in labs. |
| Spec Data | Spec Data (lims_spec_data__v) |
Data entered into the LIMS in order to set up the system for operation, such as Spec Data Criteria and Spec Data Sample Actions. |
| Spec Data Sample Action | Spec Data Sample Action (lims_spec_data_sample_action__v) |
A component of Spec Data representing the actions that can be taken on a Sample, such as Pull Sample and Test Sample. |
| Spec Data Criteria | Spec Data Criteria (lims_spec_data_criteria__v) |
The expected range of appropriate values for a given test result. These are typically defined in the protocol. Also known as specifications. |
| Spec Data Criteria Set | Spec Data Criteria Set (lims_spec_data_criteria_set__v) |
A grouping of Spec Data Criteria that pertains to a specific market or purpose. |
| Batch | Batch (quality_batch__v) |
A defined quantity of starting material, packaging material, or product processed in one process cycle. It is expected to be homogeneous. Also known as product batch. |
| Spec Execution | Spec Execution (lims_spec_execution__v) |
The runtime object that executes a specific Spec Data record, encompassing Samples, Tests, Results, and the Criteria Evaluations. |
| Lab Sample | Lab Sample (lims_sample__v) |
An amount of material taken from a specific sampling location at a specific time and subsequently tested using one or more lab methods. |
| Lab Test | Lab Test (lims_sample_test__v) |
An instance of a Test Definition performed on one or more samples. |
| Lab Test Input | Lab Test Input (lims_test_input__v) |
The consumables or instruments that are used in a test. |
| Lab Result | Lab Result (lims_result__v) |
The calculated or directly input value achieved at the conclusion of a given test. |
| Lab Storage Condition | Lab Storage Condition (lims_storage_condition__v) |
How the samples of a Study are stored. This includes things such as humidity and temperature. |
| Lab Study Design | Lab Study Design (lims_study_design__v) |
Represents the design of a Stability Study. This is the template used to generate Lab Study records and define Lab Study Design Timepoints. |
| Lab Study Design Timepoint | Lab Study Design Timepoint (lims_study_design_timepoint__v) |
The design object for when a sample should be taken out of storage and tested. |
| Lab Study | Lab Study (lims_study__v) |
Represents an ongoing lab test of our stability study sample and groups one or more Lab Study Timepoint records. |
| Lab Study Timepoint | Lab Study Timepoint (lims_study_timepoint__v) |
The time at which a group of one or more samples out of one or more Stability Chambers is pulled for testing for a Stability Study. |
LIMS Help Personas
For the purposes of this Veeva LIMS documentation, users are classified into several basic industry standard roles:
Design Data Admin
A Design Data Admin user is responsible for creating and versioning Test Definitions, Spec Data, and Sample Plans.
Lab Analyst
A Lab Analyst user is responsible for executing tests on lab samples and capturing the results.
Lab Manager
A Lab Manager is responsible for managing all the tests that need to be executed for samples received by the lab, and monitoring tests for out of control or out of specification.
Quality Authority
A Quality Authority is responsible for reviewing sample data trending and compliance to specification ranges and procedure requirements.
Vault Admin
The Vault Admin user is responsible for configuring the objects, document types, lifecycles, workflows, and other components of the Vault, to ensure a compliant LIMS implementation.